Definitions of the strength of the recommendations (A, B, C, U) and classification of the evidence (Class I through Class IV) are provided at the end of the "Major Recommendations" field.
Conclusions and Recommendations
- There are inadequate data concerning the efficacy of decompressive surgery for the treatment of diabetic neuropathy. Given our current knowledge, this treatment is unproven (Level U).
Definitions:
Classification of Recommendations
A = Established as effective, ineffective, or harmful for the given condition in the specified population (Level A rating requires at least two consistent Class I studies.)
B = Probably effective, ineffective, or harmful for the given condition in the specified population (Level B rating requires at least one Class I study or at least two consistent Class II studies.)
C = Possibly effective, ineffective, or harmful for the given condition in the specified population (Level C rating requires at least one Class II study or two consistent Class III studies.)
U = Data inadequate or conflicting given current knowledge, treatment is unproven.
Classification of Evidence for Therapeutic Articles
Class I: Prospective, randomized, controlled clinical trial (RCT) with masked outcome assessment, in a representative population. The following are required:
- Primary outcome(s) is/are clearly defined.
- Exclusion/inclusion criteria are clearly defined.
- Adequate accounting for dropouts and crossovers with numbers sufficiently low to have minimal potential for bias.
- Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences.
Class II: Prospective, matched, group cohort study in a representative population with masked outcome assessment that meets a–d above OR a RCT in a representative population that lacks one criterion a–d.
Class III: All other controlled trials including well-defined natural history controls or patients serving as own controls in a representative population, where outcome assessment is independently assessed or independently derived by objective outcome measurement (an outcome measure that is unlikely to be affected by an observer's [patient, treating physician, investigator] expectation or bias [e.g., blood tests, administrative outcome data]).
Class IV: Evidence from uncontrolled studies, case series, case reports, or expert opinion.